Option A
Recommended
PFS primary with ORR key secondary
Balanced evidentiary strength with manageable complexity.
AI Workspace for Clinical Trial Design
Turn a study brief into a review-ready trial design.
TrialCraft helps clinical teams compare design options and draft protocol-to-SAP plans faster.
- Cross-functional review, not black-box automation
- Design paths with explicit tradeoffs
- Protocol and SAP draft language
Study Brief
Population
Second-line metastatic NSCLCDesign intent
Signal-seeking, randomizedPrimary goal
Early efficacy readoutConstraints
Small n, fast startup, FDA-facing
Generated Package
3 paths ready
Option B
Higher speed
ORR primary for earlier signal detection
Faster readout, with weaker long-term evidentiary posture.
Option C
Higher rigor
Dual-endpoint design with alpha split
Stronger rigor, with more design and interpretation burden.
The Friction
Trial design is slow because every decision affects the protocol, endpoints, and analysis plan.
Study Brief
Indication
Objective
Timeline
Constraints
Population
Eligibility
Analysis
Design
Endpoints
Hypothesis
Sample Size
Protocol
SAP
Review
Revise
Align
Mismatch
Redo
Input
Design Cascade
Deliverables
Review Loops
Rework
Workflow
From brief to draft.
1
Capture the study brief
Population, phase, objective, comparator, constraints.
2
Generate design paths
Compare endpoints, assumptions, and tradeoffs side by side.
3
Draft reviewable language
Produce editable protocol and SAP language for review.
Product Mock
What appears after one study brief.
Recommended Path
PFS primary with ORR key secondary
Strong clinical signal with a familiar event-driven design.
Tradeoff
Longer time to readout than ORR
Better interpretability, slower first signal.
Assumptions
Median PFS 4.0 vs 6.3 months
HR 0.63, 1:1 randomization, one futility look.
Target Population
Second-line metastatic NSCLC
Adults with documented progression after first-line platinum-based therapy.
Cohort Definition
Randomized signal-seeking study population
Biomarker status captured at baseline with stratification factors defined before randomization.
Key Eligibility
Inclusion and exclusion aligned to the design intent
Measurable disease, adequate organ function, and prior therapy restrictions surfaced for review.
Reviewer Prompt
Confirm subgroup and screening assumptions
Enrollment feasibility, biomarker prevalence, and washout definitions flagged before protocol drafting.
Primary Endpoint
Progression-free survival
Defined as time from randomization to objective disease progression or death, whichever occurs first, per RECIST v1.1.
Estimand Note
Treatment policy framework with planned sensitivity analyses
Effect estimate summarized with a hazard ratio, confidence interval, and supportive analyses for key intercurrent events.
Analysis Population
Intent-to-treat as primary set
All randomized participants analyzed by assigned arm.
Primary Method
Stratified log-rank and Cox model
KM summaries plus supportive sensitivity analyses.
Reviewer Prompt
Confirm interim boundary assumptions
Alpha spending and censoring rules flagged for review.
Why TrialCraft
Built for how trial teams actually work.
One workspace, three teams
Clinical, regulatory, and biostat teams stay aligned from the start instead of reviewing separate documents downstream.
Assumptions you can see
Tradeoffs stay visible across endpoints, cohorts, and analysis plans instead of getting buried in spreadsheets and comments.
Editable, not automated
Draft language is reviewable and fully editable, so teams keep control of the design rather than relying on black-box output.
Domain-aware, not generic
TrialCraft understands endpoints, estimands, and analysis plans in the context of real trial design workflows.